Catalog Number

CCB7-T-C2R

Brand Name

Calf Implant, Textured, (Carlsen) SDM

Version/Model Number

Size: 21.5cm x 8.5cm x 1.6cm, Right Side

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K982688

Product Code

MIB

Product Code Name

Elastomer, Silicone Block

Public Device Record Key

fbb307d6-8db1-4217-a49c-62d67493bb45

Public Version Date

November 14, 2019

Public Version Number

3

DI Record Publish Date

August 07, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-